Clincosm LogoSign in Get a demo

VANISSh: A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer

Sponsor
Massimo Falconi (Other)
Overall Status
Recruiting
CT.gov ID
NCT04024358
Collaborator
(none)
500
Enrollment
1
Location
120
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to validate both retrospectively and prospectively a newly proposed scoring system for perineural and vascular invasion in pancreatic ductal cancer and correlate it with disease free survival, early recurrence, site of recurrence, overall survival and neoadjuvant treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Perineural invasion (PNI) is defined as the presence of cancer cells along nerves and/or within the epineural, perineural and endoneural spaces of the neuronal sheath.Clinically, PNI is associated with increased tumor recurrence, poor survival after pancreatectomy and pain, an invalidating symptom that may impair quality of life. Pancreatic ductal adenocarcinoma has one of the highest incidences of PNI (70-100%) among all types of cancer, which correlates with a poor prognosis and decreased survival. PNI is a still not uniformly characterized or quantified event, usually it is described only dichotomously ("present" or "absent"), despite some efforts to use a more detailed scoring system. However, these scores are not specifically developed for pancreatic surgical specimen. Vascular invasion (VI), which is assumed to be associated with a more aggressive tumor biology and dissemination, lacks a specific scoring system as well. The primary aim of this study is to validate both retrospectively and prospectively a novel PNI and VI scoring system aimed at a more detailed stratification of perineural invasion, together with an accompanying scoring system for vascular invasion, and correlated them with disease free survival (DFS).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer
    Actual Study Start Date :
    Jan 1, 2015
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jan 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. PNI and VI correlation with DFS [Up to 36 months]

      Analyze if the severity of perineural and perivascular invasion correlates with disease free survival

    Secondary Outcome Measures

    1. PNI and VI correlation with other clinical variables [Up to 6 years]

      Analyze if the severity of perineural and perivascular invasion correlates with major clinical variables such as early recurrence, site of recurrence, overall survival.

    2. PNI and VI correlation with neoadjuvant treatment [Up to 12 months]

      Analyze if neoadjuvant treatment impacts the severity of perineural and perivascular invasion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients older than 18 years

    • Patients undergoing all types of pancreatic resection (pancreatoduodenectomy, left pancreatectomy, total pancreatectomy, both laparotomic and laparoscopic).

    • Proven pancreatic ductal adenocarcinoma (cytology or biopsy).

    • Patients that received neoadjuvant therapy (CT +/- RT) can be included.

    • Patients able to sign the informed consent.

    Exclusion Criteria:

    • Age < 18 years.

    • Patients with other ongoing oncological diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS San Raffaele Milan Italy 20132

    Sponsors and Collaborators

    • Massimo Falconi

    Investigators

    • Principal Investigator: Marco Schiavo Lena, IRCCS Ospedale San Raffaele

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Massimo Falconi, Professor, IRCCS San Raffaele
    ClinicalTrials.gov Identifier:
    NCT04024358
    Other Study ID Numbers:
    • VANISSh
    First Posted:
    Jul 18, 2019
    Last Update Posted:
    Jul 18, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Massimo Falconi, Professor, IRCCS San Raffaele
    neural invasion
    vascular invasion
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Jul 18, 2019